BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 3223187 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01391
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. THE CTS INSTRUCTED THE CUSTOMER TO DRAIN THE BATH THROUGH THE SOLENOIDS BUT FLUID DID NOT DRAIN. THE CUSTOMER ADDED SOME BLEACH IN THE BATH TO SEND IT THROUGH THE COUNT LINE AND ALLOWED IT TO SIT, DRAIN AND RINSE TO SEE IF THIS WOULD CLEAR THE BATH. THE CUSTOMER REPORTED THAT THE BATH WAS STILL OVERFLOWING AFTER TROUBLESHOOTING WITH THE CTS. A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED THAT PINCH VALVES PV13 AND PV14 FAILED TO FIRE. THE FSE WAS ABLE TO REPLACE PINCH VALVE PV14 AND ORDERED PINCH VALVE PV13 TO INSTALL ON THE FOLLOWING DAY. THE FSE RETURNED TO THE CUSTOMER'S LABORATORY ON THE FOLLOWING DAY AND REPLACED PINCH VALVE PV13 TO RESOLVE THE LEAK AND BACKGROUND ISSUES. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO PINCH VALVES PV13 AND PV14. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 5 ML OF DILUENT LEAKED FROM THE COULTER AC*T DIFF ANALYZER. THE CUSTOMER INDICATED THAT THEIR MAIN INSTRUMENT WAS DOWN, PENDING SERVICE, AND THE CUSTOMER WAS TRYING TO GET THIS INSTRUMENT RUNNING. THE CUSTOMER STATED THAT THE INSTRUMENT PASSED STARTUP BUT HIGH LEVEL QC (QUALITY CONTROL) RESULTS WERE GOING LOWER. THE CUSTOMER PERFORMED TROUBLESHOOTING AND NOTICED THAT THE WBC (WHITE BLOOD CELL) BATH WAS NOT DRAINING AND WAS OVERFLOWING. THE CUSTOMER PERFORMED A BLEACH PROCEDURE ON THE BATH AND REPLACED THE PUMP TUBING AND FILTERS IN THE RIGHT HAND SIDE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324363 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1